1. Field of the Invention
This invention relates to an apparatus useful in the placement of a percutaneous endoscopic gastrostomy tube. In particular, the present invention is directed to an introducer attached to a receptacle about which a placement wire is positioned. Following insertion of the introducer into a selected portion of a patient""s gastrointestinal tract, the placement wire is inserted into a patient through the introducer by rotating the receptacle, thereby advancing the wire through the introducer.
The present invention also relates to a feeding tube assembly for placement in the gastrointestinal tract a patient. Particularly, the feeding tube assembly includes a feeding tube made of polyurethane, and more preferably Carbothane, and a feeding tube adaptor provided at a first end portion thereof. In accordance with one aspect of this invention, the feeding tube connector is made of a substantially rigid material and includes a retention member for friction engagement with the feeding tube. In accordance with another aspect of the invention, the feeding tube connector is provided with a cap, both of which being made of a polyurethane, wherein the cap has an engagement surface with a surface configuration different than that of a corresponding surface of the feed tube connector.
2. Description of Related Art
Gastrostomy and jejunostomy tubes are used to deliver nutritional products to the gastrointestinal tract of a patient having difficulty ingesting food. Gastrostomy tubes deliver the nutritional products percutaneously from an external source, through the patient""s abdominal wall, and directly to the patient""s stomach, while jejunostomy tubes deliver the nutritional products percutaneously into the patient""s jejunum or small bowel. In addition to primary placement percutaneously through a patient""s abdominal wall, gastrostomy and jejunostomy tubes can be placed into the patient""s gastrointestinal tract through a mature stoma formed in the abdominal wall, or through the nasal passage using nasogastric or nasojejunal tube, respectively. Gastrostomy, jejunostomy, nasogastric and nasojejunal tubes are referred to collectively herein as xe2x80x9cfeeding tubes,xe2x80x9d unless otherwise noted.
The first step for the primary percutaneous placement of a feeding tube in a patient typically involves the passing of an endoscope down the patient""s esophagus in order to view the esophagus and determine whether there are any obstructions or lesions in the esophagus that will inhibit or preclude passage of the feeding tube through the esophagus. The endoscope also is used to examine the interior of the stomach and/or the small bowel. Next, the doctor visually selects the site through which the feeding tube will be introduced into the stomach and transilluminates the selected site by directing light outwardly from the endoscope such that the light shines through the patient""s abdominal wall, thereby allowing the doctor to identify the entry site from a point outside of the patient""s body. The doctor then inserts a catheter or introducer through the patient""s abdominal wall and into the stomach at the selected entry site. A first end of a placement wire is then passed through the introducer and into the stomach. The first end of the wire is grasped using a grasping tool associated with the endoscope, and the endoscope and the placement wire are drawn outwardly from the patient""s stomach and esophagus through the patient""s mouth. Upon completing this step of the procedure, a second end of the wire remains external to the patient""s abdominal wall while the first end of the wire extends outwardly from the patient""s mouth.
Placement wires can have a variety of forms. In one commercially available embodiment, the placement wire is a doubled wire coated with a biocompatible plastic material. However, other forms of placement wires are well known. These placement wires typically are provided in a sterile package for use by a medical professional. For example, the placement wire can be coiled and placed in a sealed pouch. The wire is removed from the pouch immediately prior to placement in a patient. This packaging methodology presents certain disadvantages in that the wire is prone to entanglement during insertion into the patient. Thus, the wire must be carefully manipulated in order to ensure that it is fed properly through the introducer and into the patient. Such manipulation may result in touch contamination of the wire as it is manipulated. Further, in order to ensure that the wire is properly fed into the patient""s stomach, it is sometimes necessary to have one person manipulate the wire while a second person feeds the wire into the patient. This need for additional medical personnel increases the cost of placing the feeding tube in the patient.
In a different commercially available embodiment, the wire is a xe2x80x9csilkxe2x80x9d type pull thread that is loosely coiled in a provided holder. The thread extends through a hole in the holder and can be pulled outwardly from the holder through the hole. As the endoscope is withdrawn through the patient""s esophagus, an assistant must carefully pull the thread out of the holder and allow it to feed through the catheter. This embodiment also presents certain disadvantages due to the fact that an assistant is required in order to manipulate and feed the thread into the catheter. In addition, it typically is necessary to create a knot in the end of the thread before attaching it to a feeding tube. In some cases, creation of this knot can be difficult due to the physical characteristics of the silk thread after it has been drawn through the patient""s stomach, esophagus, and mouth.
In another commercially available embodiment, the placement wire is retained in a coil of rigid tubing. The wire can be difficult to manipulate and therefore may require the presence of an assistant to withdraw the wire from the coiled tubing. However, this embodiment does tend to reduce tangling of the placement wire during placement of the wire in the patient. Yet another commercially available embodiment includes a placement wire provided in a circular dispenser. Although this embodiment tends to minimize tangling of the placement wire, the wire still can be difficult to dispense from the circular dispenser and therefore require the presence of an assistant.
It is preferable to provide a placement wire in such a way that (a) the possibility of entanglement of the wire is minimized; (b) the possibility of touch contamination of the wire is minimized; and (c) withdrawal of the wire from its packaging does not require additional personnel. The present invention addresses each of these.
With the wire properly inserted, initial or primary placement of a feeding tube percutaneously into the gastrointestinal tract of the patient can be performed. In one technique for primary feeding tube placement, the first end of the placement wire is attached to a first end of a feeding tube. Attachment of the feeding tube to the first end of the placement wire is facilitated by a loop on the first end of the placement wire and by a complementary loop on the first end of the feeding tube. By pulling on the second end of the wire positioned external to the patient""s abdominal wall, the feeding tube is pulled through the patient""s mouth and esophagus, and into stomach. Further pulling of the second end of the wire causes the first end of the feeding tube to exit percutaneously from the stomach through a tract in the abdominal wall formed by the introducer. The feeding tube is pulled outwardly through the tract until a retaining member mounted on the second end of the feeding tube engages the interior of the stomach. This technique is referred to as a xe2x80x9cpullxe2x80x9d technique.
In an alternative technique for primary feeding tube placement, a channel defined through the feeding tube is positioned over the wire such that the feeding tube can be pushed along the length of the wire. As the feeding tube is pushed over the wire, it passes through the patient""s mouth, esophagus, and stomach until the first end of the feeding tube exits through the incision in the abdominal wall. The feeding tube is then drawn outwardly through the abdominal tract until a retaining member on the internal or second end of the feeding tube engages the interior of the stomach. The wire is then withdrawn from the patient through the feeding tube channel. This technique is referred to as a xe2x80x9cpushxe2x80x9d technique.
Yet another method may be used for percutaneous placement of the feeding tube, particularly when passage through the esophagus is precluded. This method, which is commonly known as the xe2x80x9cpokexe2x80x9d technique, is most often used for placement of a feeding tube having a balloon-type internal retaining member. Once a safe site into the stomach is identified, the poke technique requires that the stomach wall be retracted and secured against the abdominal wall of the patient using a known anchoring device, such as T-Fastenerst(copyright). One or more dilators are then used in sequence to form an adequate tract of sufficient size through which the feeding tube and the retaining member, in a deflated state, can be inserted. The retaining member is then inflated in its proper position to secure the placement of the feeding tube.
After a stoma tract has fully formed through the abdominal wall of the patient using any of the techniques summarized above, the initial feeding tube can be removed if secondary placement of a different feeding tube is desired or necessary. In this manner, a new feeding tube can be inserted directly into the mature stoma tract that is formed through the patient""s abdominal wall and retained in a conventional manner.
A variety of feeding tube configurations made of different materials are well known, and are each suitable for its intended purpose. There remains a continued need, however, for feeding tube assemblies of enhanced operational characteristics and cost effective construction.
The purpose and advantages of the present invention will be set forth in and apparent from the description that follows, as well as will be learned by practice of the invention. Additional advantages of the invention will be realized and attained by the methods and systems particularly pointed out in the written description and claims hereof, as well as from the appended drawings.
To achieve these and other advantages and in accordance with the purpose of the invention, as embodied and broadly described, the invention includes a method for placing a feeding tube placement wire in a patient. The method includes the step of providing a placement wire dispenser. The dispenser includes a rotatable placement wire receptacle that defines a placement wire outlet. The dispenser further includes a tube extending outwardly from the placement wire receptacle. The tube defines a placement wire inlet that is in communication with the placement wire outlet of the receptacle. A placement wire is wound about the receptacle, and is in mechanical engagement with the receptacle, such that rotation of the placement wire receptacle causes a first end of the placement wire to be advanced through the placement wire outlet, through the placement wire inlet of the tube, and through the tube. A first end of the tube is constructed for insertion through a patient""s abdominal wall and into a patient""s stomach. The method further includes the step of placing the first end of the tube through a patient""s abdominal wall and into a patient""s stomach. Rotational movement is imparted to the receptacle so as to advance the placement wire through the placement wire outlet, through the placement wire inlet, through the tube, and into a patient""s stomach.
The present invention also includes a placement wire dispenser. The dispenser includes a rotatable placement wire receptacle that defines a placement wire outlet. The dispenser further includes a tube extending outwardly from the placement wire receptacle. The tube defines a placement wire inlet that is in communication with the placement wire outlet of the receptacle. A placement wire is wound about the receptacle, and is in mechanical engagement with the receptacle, such that rotation of the placement wire receptacle causes a first end of the placement wire to be advanced through the placement wire outlet, through the placement wire inlet of the tube, and through the tube. A first end of the tube is constructed for insertion through a patient""s abdominal wall and into a patient""s stomach.
The present invention further is directed to a feeding tube placement kit. The kit includes a placement wire dispenser. The dispenser includes a rotatable placement wire receptacle that defines a placement wire outlet. The dispenser further includes a tube extending outwardly from the placement wire receptacle. The tube defines a placement wire inlet that is in communication with the placement wire outlet of the receptacle. A placement wire is wound about the receptacle, and is in mechanical engagement with the receptacle, such that rotation of the placement wire receptacle causes a first end of the placement wire to be advanced through the placement wire outlet, through the placement wire inlet of the tube, and through the tube. A first end of the tube is constructed for insertion through a patient""s abdominal wall and into a patient""s stomach. The kit further includes a feeding tube having a first end portion and a second end portion. The feeding tube defines a feeding lumen therethrough. A retaining member is disposed on the second end portion of the feeding tube.
The present invention also is directed to a feeding tube adaptor having an outlet conduit and an inlet conduit. An exterior surface of the outlet conduit is configured such that it has a first section having an increasing circumferential dimension from an outlet end of the adaptor to an inlet end of the adaptor. The exterior surface of the outlet conduit further is configured such that it has a second section having a decreasing circumferential dimension from an outlet end of the adaptor to an inlet end of the adaptor. The first and second sections of the exterior surface of the outlet conduit define a tube retention member, and preferably are positioned adjacent each other.
Additionally, the present invention is directed to a feeding tube assembly including a feeding tube made of a polyurethane, preferably Carbothane. The feeding tube has a first end portion, a second end portion and at least one lumen defined therein. The feeding tube assembly further includes a feeding tube adaptor having an inlet conduit and an outlet conduit, preferably made of a substantially rigid material, wherein the outlet conduit has an outlet end to be inserted into a lumen at the first end portion of the feeding tube for fluid communication therebetween. The exterior surface of the outlet conduit defines a retention member to engage an interior surface at the first end portion of the feeding tube when the outlet end of the outlet conduit is inserted within the lumen of the feeding tube. The retention member includes a first section having an exterior peripheral dimension increasing with increasing distance from the outlet end of the outlet conduit, and a second section having an exterior peripheral dimension decreasing with increasing distance from the outlet end of the outlet conduit.
In accordance with another aspect, the present invention is directed to a feeding tube assembly including a feeding tube, a feeding tube adaptor having a first inlet conduit, and a removable cap made of polyurethane to close selectively an inlet port of the first inlet conduit. The cap has an engagement surface to engage a corresponding surface of the first inlet conduit, wherein the engagement surface of the cap has a surface configuration different than that of the corresponding surface of the first inlet conduit. For example, the inlet conduit can include a port defined by an interior surface and the cap can include a plug to be inserted into the port, wherein the engaging surface of the cap is an exterior surface of the plug and the corresponding surface of the inlet conduit is an interior surface of the inlet conduit. Alternatively, the cap can include a peripheral flange, such that the engaging surface of the cap is an interior surface of the peripheral flange that engages a corresponding surface of the exterior surface of the inlet conduit. The difference in surface configurations can be established by providing one or both of the surfaces with a series of protuberances, a series of indentations, a different cross-sectional shape, or a combination thereof.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the invention claimed.
The accompanying drawing, which is incorporated in and constitutes part of this specification, is included to illustrate and provide a further understanding of the method and system of the invention. Together with the description, the drawing serves to explain the principles of the invention.